Not Yet RecruitingPhase 2/3

Dose Response Study of Transdermal Human Insulin in Patients

United States30 participantsStarted 2027-09-02

Plain-language summary

A 21-Day open label study of transdermally delivered human insulin in Type 2 Diabetics as measured by response of down modulation of glucose after dosing of Insulin as compared to historic patient response to injected insulins.

Who can participate

Age range

25 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult Type 2 Diabetes Mellitus ("T2D") Patients on Insulin Replacement therapy not administered via implanted pump well-managing p.r.n as defined by serum glucose ranging between 85 and 200 mg/dL and no more than 1 hypoglycemic or serious hypoglycemic event within the last 9 months.
. 25 and 75 years of age, inclusive.
. The subject is willing and able to read and understand the Subject Information Sheet and provide written informed consent.
. The subject has a body mass index (BMI) within 18-50 kg/m2.
. The subject is in otherwise good health as determined by medical history and physical examination.
. The subject's normal insulin dose ranges from between 10 to 200 IU per dose.
. The subject must agree to continue with daily serum glucose testing by means of a wearable blood glucose monitor for the pharmacodynamic assessments that the investigators have continuous access to via daily downloads.
. The subject is willing and able to comply with all testing and requirements defined in the protocol.

Exclusion criteria

. The subject has any relevant deviations from normal other than blood glucose in physical examination, electrocardiogram (ECG), or clinical laboratory tests, as evaluated by the investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Glucose Time in Range for Study Participants

Timeframe: 21 Days

Trial details

NCT IDNCT05159453

SponsorTransdermal Delivery Solutions Corp

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-15

Contact for this trial

Kenneth B. Kirby, BA

5614296429 KKirby@Langfordresearch.org

View on ClinicalTrials.gov More Glucose, High Blood trials